Study to Reduce Antibiotic prescription in children Pneumonia: implementation of a validated decision rule to target antibiotic prescription in children with suspected community acquired pneumonia.

- ACRONYM

STRAP

- hypothesis

The aim of this study is to reduce antibiotic prescriptions by use of a clinical decision rule in febrile children suspected for CAP with unchanged outcome. Specific research questions are:
1. Does a decision rule reduce the use of antibiotics in children with suspected CAP?
2. Does the use of a decision rule do not harm those whose treatment is modified as a result?
3. What is the compliance to a decision rule guiding clinicians on treatment for childhood CAP?
4. What is the cost benefit of the implementation of the feverkidstool in the diagnostic evaluation of a child suspected of CAP?

-febrile children with antibiotic treatment during the week prior to the ED visit
-children with comorbidity, i.e. hemodynamic relevant cardiac disease, pulmonary, neurologic disease or (primary of secondary) immunodeficiency
-children with an obvious single other infectious focus (cutaneous, otitis media, rhinitis), those with signs of complicated pneumonia at the moment of presentation (i.e. respiratory failure, pleura empyema, pneumothorax, suspicion of septicaemia), those with (self-reported) intolerance of amoxicillin, and those with suspicion of resistant pathogens due to a visit to foreign countries 2 months prior to the ED visit
-patients not understanding or not able to act on safety-net instructions (due to language problems or logistics) in case of deterioration

- mec approval received

yes

- multicenter trial

yes

- randomised

no

- group

[default]

- Type

Single arm

- Studytype

intervention

- planned startdate

1-okt-2015

- planned closingdate

31-dec-2017

- Target number of participants

1100

- Interventions

-Feverkidstool: a clinical decision rule that assess the individual risk for pneumonia in children with fever
-a risk based strategy for treatment advice (discharge, watchfull waiting, or antibiotics) will be applied

- Primary outcome

Number of (narrow-spectrum) antibiotic prescriptions and its percentage within the total included population (benefit); Strategy failures (children with complications of CAP within 7 days) (safety).

- Secondary outcome

-Compliance to the advice of the feverkidstool; percentage and number of narrow versus broad-spectrum antibiotic prescriptions; Duration and dosages of antibiotic prescriptions
-Safety: Number of complications of pneumonia, association of isolated pathogens with complicated CAP course

Unnecessary prescription of antibiotics highly contributes to the development of antibiotic resistance, a world wide threat to
health. We are in need to improve the recognition of children that benefit from antibiotic treatment for comunity-acquired
pneumonia (CAP).
Aim:
To safely reduce antibiotic prescription by a clinical decision rule (Feverkidstool) in febrile children suspected of CAP.
Design:
Stepped wedge trial with implementation of the Feverkidstool guiding antibiotic treatment in children suspected of CAP in 7
hospitals.
Population:
Febrile children (1 month – 5 years) at the emergency care department with signs of CAP in 7 Dutch hospitals.
Outcomes:
Primary: Number of antibiotic prescriptions (benefit); strategy failures within 7 days (safety). Secondary: Compliance to the rule;
Percentage of narrow spectrum antibiotics; Duration/doses of antibiotics; Complications of CAP; Costs of outcome measures.
Intervention:
Clinical decision rule (Feverkidstool) for the individual risk for CAP and other SBI guiding a targeted approach for antibiotic
prescription.
Analysis:
A generalized linear mixed model with antibiotic prescription as dependent will be used to correct for clustering in centers and
time-effects. Time-effects will be included as fixed effect. Covariates includes the predicted risk for CAP (low, intermediate and
high), patient age, triage urgency and season.
Power analysis:
A sample size of 1100 children with a suspicion of CAP in 24 months will be sensitive to detect an absolute reduction of 10%
(low risk) to 15% (intermediate risk) of antibiotic prescription with a power of 0.9 and an alpha of 0.05.
Schedule:
M0-3: preparation; M4-15 datacollection preimplementation; M13-15 implementation; M16-M27 datacollection
postimplementation; M28-30 Datanalysis, reporting.
Impact:
The Feverkidstool improves application of current insights on reduced antibiotic presicription in children suspected of CAP in
routine care.